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ClinicalTrials.gov ID

NCT07317037

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

208Estimated

Last Update Posted

Jan 7, 2026Actual

Start Date

Mar 1, 2026Estimated

Primary Completion Date

Dec 1, 2027Estimated

Completion Date

Aug 1, 2028Estimated

Official Title

ActiTENS Mini (Transcutaneous Electrical Stimulation) in Women With Chronic Pain From Pelvic Endometriosis : a Randomized, Controlled Multicenter Cross-over Study Compared to Weak TENS Treatment, Followed by an Open-label Extension Phase

Brief Summary

Endometriosis is a condition that often causes pelvic pain, particularly during menstruation but also continuously and over long periods. Pharmacological treatments are only moderately effective or are associated with adverse effects. In this context, the search for non-pharmacological approaches to endometriosis pain is essential. Transcutaneous electrical nerve stimulation (TENS) is a portable pain relief technique that is rapidly developing for the treatment of endometriosis pain. The protocol presented aims to confirm the analgesic efficacy of this treatment for endometriosis pain. It will involve 27 gynecology and pain departments in mainland France. It will offer 30-minute sessions of daily stimulation, either suprapubic or lumbar. Several types of stimulation will be compared, with three 3-month phases, two blind phases, and a 3-month phase in which the system used will be fixed. The aim will be to reduce pain intensity as well as other parameters relating to quality of life and the impact of pain. If the effectiveness of this device is confirmed, it could lead to TENS being made available for endometriosis pain and potentially prescribed by gynecologists and midwives.

Detailed Description

The study will be proposed to women of adult age during a routine consultation for endometriosis-related pain, in gynecology and pain centers, in France, if they meet the inclusion and exclusion criteria of the study.

Information will be given to them and a necessary period of reflection not exceeding one week will be granted to them.

First phase: a cross-over trial After giving their informed consent, women will be included and randomized either to the actiTENS mini treatment arm or to the low activity treatment arm for 3 months, followed by a wash out period of 28 days. After this first cross-over period, women initially randomized to the actiTENS mini arm will be switched to the low activity arm for 3 months, inversely patients initially in the low activity treatment arm will be switched to the actiTENS mini treatment for the same duration of 3 months.

During the first cross-over study, women will be treated 60 minutes twice daily by a TENS device applied both on the pelvic anterior and sacral posterior region, with the P2 program.

Second phase: an open-label trial After a wash out period of 28 days, all patients will enter the 3-month open phase where only actiTENS mini treatment will be prescribed for 3 months, women choosing freely the region of stimulation (anterior, posterior or both), the program of stimulation and the duration of stimulation.

• Endometriosis

• actiTENS mini - weak stimulation
• weak stimulation - actiTENS mini

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Women over 18 years old
• Followed-up in gynecology consultation for endometriosis confirmed by specific imaging (MRI or ultrasound)
• Referred to a gynecological or a pain center
• With chronic pelvic pain (for at least 3 months) related to endometriosis, pelvic pain being the predominant symptom of endometriosis: pelvic pain present at least 15 days per month in the previous 3 months
• Stable and optimal analgesic and hormonal treatments during the last 3 months: any modification of pharmacological treatment in the last 3 months
• Pelvic pain of moderate to severe intensity or greater than or equal to 4 on an NRS of 0-10 on average during the 8 days preceding the inclusion visit and during the inclusion visit.
• Informed about the concept and accepting the use of TENS as a device, a non-drug analgesic treatment.
• Able to understand the use of TENS
• Having a personal smartphone enabling the EndoTENS application to be downloaded
• All women of childbearing potential (WOCBP) must agree to maintain highly effective contraception by practicing abstinence or by using an effective method of birth control from the date of consent through the end of the study: Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (Oral, Intravaginal, Transdermal); Progestogen-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable); Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomized partner, spermicide-coated condoms
• Willingness and ability to attend the scheduled study visits and comply with study procedures
• Affiliated to Social Security.

Exclusion Criteria:

• Symptoms of endometriosis other than pelvic pain, predominant over pelvic pain (pelvic pain is not the main symptom): digestive disorders, unstable bladder, dyspareunia, infertility, fibromyalgia, sciatica, low back pain…
• Present or past allergy to actiTENS mini pads.
• Pelvic surgery planned within the next 11 months.
• Drug or non-pharmacological treatments not stabilized, which could influence the pathology studied during the last 3 months
• Changed of treatments for endometriosis planned in the next 10 months.
• Patient presenting an absolute contraindication to TENS: patient with epilepsy, patient with a defibrillator, a pacemaker, a cochlear implant or other implanted electronic devices, patient with cardiac disorders, patient with decreased or altered sensation or sensitivity in the area to be treated, for example patients with allodynia (pain triggered by a stimulus that is normally painless) in the area to be treated.
• Patient unable to express his consent or patient in deprivation of liberty.
• Patient that already used or know the functioning principles of a TENS device previously to the clinical study
• Contraindications to actiTENS mini
• Pregnancy and breastfeeding
• Patients under guardianship or curatorship and protected adults
• Patients on AME (Aide Médicale de l'Etat = State Medical Assistance)
• Current participation in another research study involving a therapeutic intervention. Participation to an observational research, or a non-interventional research is allowed

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Crossover Assignment

Masking

None (Open Label)

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Collaborators

SUBLIMED (Donation of DMs and application development)UNKNOWN

Ministry of Health, FranceOTHER_GOV

horace.roman@gmail.com05 64 10 09 45

jamard-e@chu-caen.fr02 31 06 31 06

xavier.deffieux@aphp.fr01 45 37 44 87

marc.siffert@aphp.fr01 47 60 63 39

Yann.Salhi@chicreteil.fr01 57 02 22 44

tmichy@chu-grenoble.fr04 76 76 75 75

perrine.capmas@aphp.fr01 45 21 77 14

Chrystele.RUBODDITGUILLET@chu-lille.fr03 20 44 67 57

gil.dubernard@chu-lyon.fr04 72 07 16 42

pierre-adrien.bolze@chu-lyon.fr04 78 86 65 96

audrey.pivano@ap-hm.fr04 91 38 37 02

Antoine.NETTER@ap-hm.fr04 91 38 00 00

E.MARTIN@chru-nancy.fr03 83 85 82 21

Claire.CARDAILLAC@chu-nantes.fr

amelia.favier@aphp.fr01 42 17 81 33

louis.marcellin@aphp.fr01 58 41 36 61

serge.perrot@aphp.fr+33 1 58 41 15 40

cabo@ghpsj.fr01 44 12 84 84

anne-sophie.bats@aphp.fr01 56 09 35 86

martin.koskas@aphp.fr01 40 25 76 10

Delphine.RANNOU@chu-poitiers.fr05 49 44 39 15

christophe.poncelet@ght-novo.fr01 30 75 40 75

ograesslin@chu-reims.fr03 26 78 35 17

Krystel.NYANGOH.TIMOH@chu-rennes.fr02 99 26 71 20

celine.chauleur@chu-st-etienne.fr04 77 82 86 11